AutismNCT04788537
Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
A study testing Training to Understand and Navigate Emotions and Interactions (TUNE In) in people with Autism and Autism Spectrum Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to test a novel, three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder, Autistic Disorder
- What is being tested?
- Training to Understand and Navigate Emotions and Interactions (TUNE In)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2021to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of autism spectrum disorder
Who cannot join
- intellectual disability
- severe mood or psychotic symptoms experienced in the past 4 weeks
- severe self-injurious or aggressive behavior
- severe extrapyramidal motor or sedating side effects of medications
- concomitant participation in another social skills treatment program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to test a novel, three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder.
The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.
The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.
- Conditions
- Autism, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome, Pervasive Developmental Disorder
- Being tested
- Training to Understand and Navigate Emotions and Interactions (TUNE In)
- Keywords
- Autism, Autism Spectrum Disorder, Cognitive Behavioral Therapy
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Asperger Syndrome, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training to Understand and Navigate Emotions and Interactions (TUNE In)Behavioural
A three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. TUNE In includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Training to Understand and Navigate Emotions and Interactions (TUNE In) |
| Nonintervention Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report)
Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology.
Measured: Baseline and Post-Treatment (~1 year after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start16 Feb 2021
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomly assigned to either the intervention group (50%) or nonintervention group (50%).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788537
- Sponsor's protocol ID
- 820694
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2021
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available through NIH NDAR registry
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT04788537
- Acronym / sponsor ID
- 820694
- Conditions
- Autism, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome, Pervasive Developmental Disorder
- Keywords
- Autism, Autism Spectrum Disorder, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a novel, three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder.
The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.
The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomly assigned to either the intervention group (50%) or nonintervention group (50%).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Training to Understand and Navigate Emotions and Interactions (TUNE In) |
| Nonintervention Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of autism spectrum disorder
Key exclusion criteria (5 listed)
- intellectual disability
- severe mood or psychotic symptoms experienced in the past 4 weeks
- severe self-injurious or aggressive behavior
- severe extrapyramidal motor or sedating side effects of medications
- concomitant participation in another social skills treatment program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training to Understand and Navigate Emotions and Interactions (TUNE In)A three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. TUNE In includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. | Behavioural | Intervention Group |
Primary outcome
Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report)
Time frame: Baseline and Post-Treatment (~1 year after baseline)
Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be available through NIH NDAR registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training to Understand and Navigate Emotions and Interactions (TUNE In) in people with Autism and Autism Spectrum Disorder, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report) (time frame: Baseline and Post-Treatment (~1 year after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.